Kornimate/medical-research-clean huggingface dataset:
dexmedetomidine versus clonidine for transversus abdominis plane block in patients undergoing elective caesarean section

Conditions: Postoperative Pain

Summary: aim to study the efficacy of co-administered dexmedetomidine or clonidine with bupivacaine and that of bupivacaine 0.25% alone for transversus abdominis plane (tap) block for postoperative analgesia in patients undergoing elective caesarean section. * group 1: bupivacaine 0.25% + dexmedetomidine 0.5 mcg/kg (a total volume of 40 ml (20 ml each side) was used for the tap block.) * group 2: 20 ml bupivacaine+1ug/kg clonidine bilaterally (a total volume of 40 ml (20 ml each side) was used for the tap * group3: bupivacaine 0.25% + placebo (a total volume of 40 ml (20 ml each side) was used for the tap a prospective randomized interventional double-blind study.

women, following caesarean delivery, have even more compelling reasons to receive optimal post-operative pain relief, for improved maternal and neonatal well-being. also, adequate pain relief helps the patient to ambulate early and prevent any thrombotic incidents . dexmedetomidine, an imidazole compound, is the pharmacologically active dextroisomer of medetomidine that displays specific and selective α 2-adrenoceptor agonist activity and causes sedation, analgesia without any delirium, or respiratory depression. the mechanism of action is unique and differs from those of currently used agents, including clonidine.

Eligibility criteria:
inclusion criteria: * parturients scheduled to undergo cesarean section under spinal anesthesia exclusion criteria: * patients who refused spinal anesthesia * women with chronic pelvic pain or on chronic morphine use * history of drug allergy * coagulation disorder

Keywords: bupivacaine dexmedetomidine clonidine transversus abdominis plane block
clinical study to monitor plasma levels of 24ohc in subject with hd

Conditions: Huntington Disease

Summary: a 2-year clinical longitudinal study to measure plasma concentrations of 24s-hydroxycholesterol, a brain-derived cholesterol catabolite, in subjects with huntington disease, from the presymptomatic to the symptomatic stages.

in cross-sectional studies, the plasma level of brain-derived 24s-hydroxycholesterol (24ohc) has been found to be significantly diminished in hd patients from the first stages of the disease. furthermore, in hd gene-positive pre-symptomatic (pre-hd) the plasma levels can predict the development of motor signs of disease in subjects closer to onset, better than in subjects far from onset. these data suggest that circulating 24ohc might be a candidate biomarker for phenotypic conversion and for disease progression in different stages of the disease. detailed neurological, cognitive and imaging data and blood samples will be collected at baseline, and after two years to investigate the rate of changes along the longitudinal study. isotope dilution mass spectrometry (assay performed at istituto di ricerche farmacologiche mario negri irccs) will be used to measure the plasma levels of brain-derived 24ohc and other sterols reflecting peripheral cholesterol synthesis. the investigators expect to establish whether changes in plasma 24ohc mark disease progression and, eventually, phenoconversion from pre-symptomatic to symptomatic stages in combination with clinical, cognitive and imaging parameters.

Eligibility criteria:
inclusion criteria: symptomatic hd subjects 1. age ≥ 18 years 2. known family history of hd and genetically confirmed disease by direct dna test (cag expansion \> 35 repeats) 3. clinical diagnostic motor features of hd, defined as score\> 5 at the motor unified huntington disease rating scale (muhdrs) 4. stage i or ii or iii hd, defined as uhdrs total functional capacity (tfc) scores between 3 and 13 inclusive (marder, 2000) presymptomatic hd subjects 1. age ≥ 18 years 2. known family history of hd and genetically confirmed mutation by direct dna test (cag expansion \> 35 repeats) 3. absence of clinical motor features of hd, defined as muhdrs rating scale ≤ 5 healthy subjects 1. age ≥ 18 years 2. absence of known family history of hd or genetically confirmed negative dna test for hd (cag expansion ≤ 35 repeats) 3. absence of clinical motor features of hd, defined as muhdrs rating scale ≤ 5 exclusion criteria: 1. participation in clinical pharmacological trials 2. inability to undergo and tolerate mri scans (e.g. claustrophobia, severe chorea, mri-incompatible intrauterine devices, metal implants, ect) 3. inability or unwillingness to undertake any of the study procedures

Keywords: huntington disease cholesterol
rare iron overloads except c282y homozygosity : description and characterization.

Conditions: Rare Iron Overloads Except C282Y Homozygosity

Summary: chronic iron overload is responsible for morbidity and mortality. there are many genetic and acquired causes. one of them is an hepcidin deficiency. hepcidin is the regulating hormone for iron. the study explores this specific cause, and aim to characterize this iron overload in term of clinical, biological, genetic and functional specificities.

one of chronic iron overload profiles is a deficit in hepcidin. hepcidin is the regulating hormone for iron. this specific profile is characterized by an elevated serum iron, an elevated transferrin saturation, and parenchymal damages of iron overload. this disease is not connected with known mutations of iron metabolism genes. the main objective of this study is the clinical, biological, genetic and functional characterization of rare iron overload phenotypes associated with hepcidin deficiency except c282y homozygosity.

Eligibility criteria:
inclusion criteria: * biological profile suggesting hepcidin deficiency: * high serum iron (\> 25μmol / l) checked at least 2 times. * increased transferrin saturation coefficient (\> 50 %) checked at least 2 times, and calculated from transferrinemia. * proved hepatic iron overload: using a dosage of iron hepatic concentration either on hepatic biopsy, or by mri according to the method of iron overload quantification. a threshold of 100 µmol / g is set. * patient's written consent for examination and collection of genetic data to set the diagnosis. non inclusion criteria: * hfe hemochromatosis: c282y/c282y homozygosity * treatment by iterative phlebotomies (more than 2 phlebotomies) * hematological diseases with dyserythropoiesis and/or repeated transfusions * low haptoglobin level, suggesting chronic hemolysis or myelodysplasia * long-term iron oral and/or parenteral supplementation

Keywords: rare iron overload hepcidin
does testosterone improve function in hypogonadal older men

Conditions: Hypogonadism

Summary: this is a randomized controlled trial of testosterone replacement therapy in hypogonadal men age \> 60 years. the goal is to assess the safety and efficacy of trt in men age \> 60 years.


Eligibility criteria:
inclusion criteria: age 60-80 yrs serum total testosterone \< 300 ng/dl serum bioavailable testosterone \< 70 ng/dl exclusion criteria: unable to provide informed consent history of prostate or breast cancer untreated sleep apnea

Keywords: hypogonadism testosterone aging total testosterone < 300 ng/dl bioavailable testosterone < 70 ng/dl
withings devices follow-up study - hypertension

Conditions: Hypertension

Summary: the primary objective is to evaluate the accuracy to predict uncontrolled hypertension with withings device data.


Eligibility criteria:
inclusion criteria: * male or female who are 21 years of age or older, * participant living in the united states, * participant with data recorded in withings database, * active withings device users having at least 2 years of data, * subject able to read, understand, and provide written informed consent, * subject willing and able to participate in the study procedures as described in the consent form, * subject able to communicate effectively with and willing to follow instructions from the study staff. exclusion criteria: * minors under 21 years old, * subject who refused to participate in the study, * subject who did not reply to the questionnaire, * subject who objected to the processing of his or her data after the start of the study.
endometrial shedding prior to ovulation induction pilot study

Conditions: Infertility

Summary: this is a pilot study examining the feasibility of implementing a large randomized control trial looking at the effect of endometrial shedding with medroxyprogesterone acetate compared to no pre-treatment in women taking clomiphene citrate for ovulation induction for infertility due to oligo-ovulation or anovulation.

the purpose of this pilot study is to assess the feasibility of implementing a randomized controlled trial assessing the effect of giving medroxyprogesterone acetate (mpa) to induce a withdrawal bleed compared to a control group of women not receiving mpa on pregnancy rates prior to ovulation induction with clomiphene citrate in oligo-ovulatory and anovulatory women. the primary outcome measure is the effective implementation of the study including a measure of time to recruit 50 patients, physician, nursing and patient compliance rate with the study protocol, and patient satisfaction. secondary outcome measures include the pregnancy rate per ovulation (where pregnancy is defined as a positive fetal heart rate on ultrasound 2 weeks after a positive pregnancy test), the ovulation rate per cycle started, conception rate per cycle started (where conception is defined as a positive beta-human chorionic gonadotropin level), conception rate per ovulation, time to complete 3 stimulation cycles and endometrial thickness at time of luteinizing hormone surge.

Eligibility criteria:
inclusion criteria: * oligo-ovulation defined as having less than or equal to 8 menstrual cycles in the past year or inter-menstrual periods of 45 days or longer * general good health * ability to have timed intercourse or intrauterine insemination * no evidence of tubal dysfunction * no evidence of a uterine cavity abnormality * no evidence of male factor infertility exclusion criteria: * a baseline ultrasound showing an endometrial lining greater than 1.0 cm * a baseline ultrasound showing an endometrial lining of less than 0.5 cm * a positive progesterone level at baseline bloodwork * a positive beta human chorionic gonadotropin level at baseline bloodwork * body mass index of greater than 40 * women who have previously taken clomiphene citrate for ovulation induction within the last 6 months * women who are taking metformin * women who are taking a progestin for luteal phase support.
the effect of oxygen administration on regional cerebral oxygen saturation (rso2) in the non-block side after stellate ganglion block

Conditions: SSNHL(Sudden Sensory Neural Hearing Loss)

Summary: stellate ganglion block (sgb) is known to increase blood flow to the innervation area of the stellate ganglion. near infrared spectroscopy reflects changes of blood volume and allows continuous, non-invasive, and bedside monitoring of regional cerebral oxygen saturation (rso2). previous studies have shown the increment of the rso2 on the block side from the baseline and the decrement of the rso2 on the non-block side after sgb. patients with cerebral vascular disease undergoing sgb might be at risk a decrease in cerebral blood flow in the non-block side. the investigators researched the effect of oxygen administration on rso2 in the non-block side using a near infrared spectroscopy after sgb. 5 l/min oxygen was supplied via nasal cannula from 15 minutes after sgb. the rso2 in the non-block side were measured before sgb and 5, 10, 15, 20, 25 and 30 minutes after sgb. the present study suggests that oxygen administration can increase the rso2 of non-block side. in conclusion, it is our belief that oxygen supplement is helpful to the patient with cerebral vascular disease during sgb.


Eligibility criteria:
inclusion criteria: * ages between 20 and 70 years * asa ps 1,2 * disease entity : pain in the head, neck, upper extremity, and ssnhl ( sudden sensory neural hearing loss ) exclusion criteria: * patient with the tendency to bleed * patient who had cerebrovascular disease * patient with respiratory disease ( copd: chronic obstructive lung disease ) * patients who do not give written informed consent to participate in the study
protective effect of beraprost sodium tablets on reperfusion therapy for acute stemi

Conditions: Essential Hypertension

Summary: protective effect of beraprost sodium tablets on coronary microcirculation function and ventricular remodeling after reperfusion therapy for acute st segment elevation myocardial infarction


Eligibility criteria:
inclusion criteria: * it meets the diagnostic criteria of acute st segment elevation myocardial infarction: ischemic chest pain lasts for more than 30 minutes and can not be relieved by taking nitroglycerin; st segment elevation of ecg with two or more adjacent leads, limb lead ≥ 1mm, chest lead ≥ 2mm; or new left bundle branch block; the serum markers of myocardial necrosis increased at least twice the normal value * acute myocardial infarction was confirmed by coronary angiography * the clinical and angiographic data were complete * direct pci was performed within 12 hours after onset exclusion criteria: * those who do not cooperate in the inspection, have poor compliance and cannot guarantee the completion of the test * conscious disorder, obvious intellectual disorder and mental disorder * with metal foreign bodies, such as metal prosthesis, intraocular metal foreign bodies, intracranial aneurysm clamp, etc * people with claustrophobia * had a history of myocardial infarction, pci and coronary artery bypass grafting * factors affecting st segment changes of ecg: complete left bundle branch block, preexcitation syndrome, pacemaker ecg, etc
evaluation of potential for drug interaction between sch 58235 (ezetimibe) and pitavastatin (study p03962)(completed)

Conditions: Hypercholesterolemia

Summary: this study was designed to evaluate the pharmacokinetic interaction and safety of coadministration of sch 58235 (ezetimibe) and pitavastatin in healthy japanese adult male subjects or adult male subjects having no obvious disease other than high cholesterol levels.


Eligibility criteria:
inclusion criteria: * healthy adult male subjects meeting all the criteria below or adult male subjects having no obvious disease other than high cholesterol levels. * aged 20 years or over and 65 years or below when the informed consent is obtained. * weighing 50 kg or over and 80 kg or below on the day of the screening tests, with bmi \[body mass index: body weight (kg)/height (m)2\] ranging from 16.5 to 27.5. exclusion criteria: patients meeting any one of the following conditions are excluded from the study. * subjects with the triglyceride value at screening test exceeding 500 mg/dl. * subjects with past history of drug allergy (shock, anaphylactic symptom, and angioedema). * subjects with past history of alcohol or drug dependence. * subjects with past history of mental disorder. * subjects positive in the test for hbs antigen, hcv antibody, or hiv antibody or in the serological test for syphilis. * subjects who used any drug within 2 weeks of investigational product administration in period 1. * subjects who have drawn more than 400 ml of blood within 12 weeks before administration day in period 1. * subjects who participated in other study within 16 weeks of investigational product administration in period 1 and was administered a investigational product. * subjects who cannot take contraceptive measures during the study period (from providing informed consent to completion of period 3 examination) * subjects who the investigator judges are inappropriate to participate in the study.
hyperopic lasik with crosslinking versus standard lasik

Conditions: Hyperopia

Summary: analysis corneal and refractive stability of hyperopic laser-assisted in situ keratomileusis (lasik) with and without concurrent prophylactic high-fluence cross-linking (cxl).

interventional prospective consecutive comparative case control series of cases; 50 eyes of 25 patients with mean age 35.7 ± 12.4 (range 18-61years) with hyperopia or hyperopic astigmatism underwent customized lasik with concurrent prophylactic high-fluence cross-linking in right eye (group 1) and customized lasik only in left eye (group 2). cases with hyperopia +1 diopter to +6 diopters or hyperopic astigmatism up to 4 diopters were included in the study. patients with previous intraocular or corneal surgery, active corneal disease were excluded from the study. main outcome measures were uncorrected visual acuity (ucva), manifest refractive spherical equivalent (mrse), cycloplegic refractive spherical equivalent (crse), keratometric measurements and spherical aberrations at 4 mm and maximum pupil and their evolution along 6 months postoperatively.

Eligibility criteria:
inclusion criteria: * cases with hyperopia +1diopter to +6 diopters or hyperopic astigmatism up to 4 diopters exclusion criteria: * patients with previous intraocular or corneal surgery, active corneal disease
targeting beta cell dysfunction with verapamil in longstanding t1d

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to determine whether verapamil can transiently improve beta cell function in those who do or do not secrete proinsulin and little/no c-peptide.


Eligibility criteria:
inclusion criteria: 1. ≥ 3 years from type 1 diabetes diagnosis 2. males and females 18-50 years of age, inclusive 3. peak mmtt stimulated c-peptide \< 0.017 pmol/ml 4. females of child-bearing potential must be willing to use effective birth control for 12 weeks 5. willing and able to give informed consent for participation 6. hba1c ≤ 8.5% exclusion criteria: * concurrent use of non-insulin therapies aimed to control hyperglycemia or use within the past 30 days of initial qualifying mmtt (v-2). 2. diagnosis of liver disease or elevated hepatic enzymes, as defined by alt or ast\> 1.5 x the upper limit of age-determined normal (uln). 3. renal disease, as defined by creatinine ≥1.5 mg/dl. 4. hypersensitivity to verapamil or any component of the formulation. 5. previous use of verapamil. 6. known left ventricular dysfunction; bradycardia (hr \ 10 mg daily; lovastatin \> 20 mg; pravastatin \> 20 mg 9. use of other medications which may increase the concurrent risk of verapamil use, including medications which utilize the cytochrome p450 enzyme pathway. 10. females who are pregnant or lactating. 11. receipt of an immune modulating biologic or investigational drug within 3 months or 5 half-lives before enrollment. 12. history of other clinically significant autoimmune disease except for celiac and stable thyroid disease. 13. current use of any medication known to significantly influence glucose tolerance (e.g. oral steroids, atypical antipsychotics, diphenylhydantoin, niacin). 14. any medical or psychological condition that in the opinion of the principal investigator would interfere with the safe completion of the trial. conditions to consider include history of chronic gerd, chronic constipation, and chronic nausea. 15. specific to mri subjects: non-removable ferromagnetic materials or mri not technically feasible (claustrophobia, movement disorder, obesity).
open-label comparative study of risperidone versus olanzapine versus quetiapine for mania in children and adolescents with bipolar i and bipolar ii disorder

Conditions: Bipolar Spectrum Disorder

Summary: the objective of this study is to compare the safety and effectiveness of risperidone, olanzapine, and quetiapine in the treatment of mania in children and adolescents with bipolar disorder over 8 weeks and then over an extension phase. this is an exploratory, open-label study, which seeks to determine if there is evidence for efficacy. the results of this study will be used to generate hypotheses for a larger study.


Eligibility criteria:
inclusion criteria: * males and females age 6 to 18 years of age * patient must have a diagnosis of bipolar i or bipolar ii disorder and currently displaying an acute manic, hypomanic, or mixed episode (with or without psychotic features) according to the dsm-iv based on clinical assessment and confirmed by structured diagnostic interview (kidd schedule of affective disorders). * patients must have an initial score on the y-mrs total score of at least 15. * patient must be able to participate in mandatory blood draws. * patient must be able to swallow pills. exclusion criteria: * patients with chronic medical illness, dsm-iv substance dependence within the past 6 months, pregnant or nursing females, and those at serious risk of suicide will be excluded from the study
evaluation of treatment response with integrated mri/pet in patients with hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to explore the ability of integrated mri/pet to detect and evaluate treatment outcome in hcc patients.

this study using 18f-fdg pet and functional mri (dce-mri, diffusion-weighted mri, mr spectroscopy).

Eligibility criteria:
inclusion criteria: 1. prior informed consent form 2. at least one measurable tumor, according to recist version 1.1. 3. age \> 20 years. 4. ecog performance status 0 or 1. 5. life expectancy \> 3 months. 6. confirmed diagnosis of hcc 7. adequate renal function (serum creatinine ≦ 1.5 x upper limit of normal). exclusion criteria: 1. age \<20 years old 2. pregnancy 3. contraindication for mri: claustrophobia or mr non-compatible devices 4. contraindication for mr contrast medium: severe adverse reaction or impaired renal function (cre \> 2.0) 5. history of other malignancy

Keywords: mr/pet, hepatocellular carcinoma, hcc
permissive hypotension after cardiac surgery

Conditions: Surgery

Summary: the objective of this pilot randomized controlled trial is to demonstrate the feasibility of implementing a pragmatic clinical trial randomizing patients to permissive hypotension versus usual care and to determine the impact of permissive hypotension on vasopressor exposure, icu length of stay, markers of end organ perfusion, and clinically relevant patient outcomes. the data collected from this pilot study will be used as preliminary data for study design and grant applications for a larger multicenter randomized controlled trial.

the investigators will perform a single center, open-label, randomized controlled trial in patients admitted to the hcicu after cardiac surgery at mgh. patients who are hypotensive (map \ 60mmhg) or b) usual care. the duration of the intervention will extend until the patient no longer needs vasopressors to maintain prespecified map. outcomes of interest include continuous hemodynamics (both recorded values from ehr as well as the arterial line waveform data), vasopressor exposure (as measured by maximum vasopressor-inotrope score, mean vasopressor-inotrope score, and duration of vasopressor use), lactate clearance, rates of atrial fibrillation, need for renal replacement therapy, icu length of stay, survival to hospital discharge, cognitive state at discharge using montreal cognitive assessment score. additionally, the investigators will perform exploratory analyses using the continuous arterial line waveform data to evaluate for potential differences in arterial waveform morphologies between groups to help discern the hemodynamic impacts of permissive hypotension and to potentially identify subphenotypes who may derive greater benefit.

Eligibility criteria:
inclusion criteria: * 18 years or older * schedules for elective or non-emergent cardiac surgery exclusion criteria: * arrival to the cicu with severe shock determined any of the following: norepinephrine dose \>20mcg/min, epinephrine \>3mcg/min, dobutamine \>2.5mcg/kg/min, milrinone \>0.2mcg/kg/min * rapidly increasing pressors within 60 mins of arrival. * significant prior renal dysfunction (ckd \>4), hemodialysis dependence * cirrhosis * a neuropathology diagnosis warranting blood pressure goal * pre-specified map goal as determined by clinical team * carotid stenosis (\> 50%) or prior stroke * bleeding requiring return to the or * need for mechanical circulatory support * heart and lung transplantation * aortic dissection